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Cuvposa Approval History

  • FDA approved: Yes (First approved July 28th, 2010)
  • Brand name: Cuvposa
  • Generic name: glycopyrrolate
  • Dosage form: Oral Solution
  • Company: Shionogi Pharma Inc.
  • Treatment for: Chronic Drooling in Children

Cuvposa (glycopyrrolate) oral solution is an anticholinergic for the treatment of chronic severe drooling caused by neurologic disorders in children.

Development History and FDA Approval Process for Cuvposa

Jul 29, 2010Approval FDA Approves Cuvposa for Chronic Drooling in Children
Sep 29, 2009Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

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